Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers’ Fear of Hypoglycemia and Improves Their Well-being
Carine de Beaufort, Ulrike Schierloh, Ajay Thankamony, Julia Ware, Malgorzata E. Wilinska, Elke Fröhlich‐Reiterer, Thomas Kapellen, Birgit Rami‐Merhar, Sabine E. Hofer, Fiona Campbell, James Yong, Laura E. Bocchino, Judy Sibayan, Julia Lawton, Stéphane Roze, Maria Fritsch, Alena Gerlinde Thiele, Janet M. Allen, Charlotte K. Boughton, Julia K. Mader, Craig Kollman, Roman Hovorka, Ineke Pit-Ten Cate, Roman Hovorka, Carlo L. Acerini, Ajay Thankamony, Charlotte K. Boughton, Klemen Dovč, Julia Ware, Gianluca Musolino, Malgorzata E. Wilinska, Janet M. Allen, Sara Hartnell, Yue Ruan, Nicole Ashcroft, Matthew Haydock, Catherine Hill, Carine de Beaufort, Ulrike Schierloh, Muriel Fichelle, Dominique Schaeffer, Elke Fröhlich‐Reiterer, Maria Fritsch, Hildegard Jasser‐Nitsche, Julia K. Mader, Kerstin Faninger, Thomas Kapellen, Heike Bartelt, Alena Gerlinde Thiele, Birgit Rami‐Merhar, Gabriele Berger, Nicole Blauensteiner, Renáta Gellai, Katrin Nagl, Martin Tauschmann, Sarah Cvach, Sonja Katzenbeisser-Pawlik, Sabine E. Hofer, Daniela Abt, Anita Malik, Barbara Lanthaler, Matthias Wenzel, Fiona Campbell, James Yong, Emily Metcalfe, Majorie Allen, Sarah Ambler, Saima Waheed, Jane Exall, Joseph Tulip
Abstract
OBJECTIVE: To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers' well-being, fear of hypoglycemia, and sleepiness. RESEARCH DESIGN AND METHODS: We conducted a multinational, open-label, randomized crossover study. Children (age 1-7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization-Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires. RESULTS: Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09). CONCLUSIONS: Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.